Dive Brief
Johnson & Johnson has begun a clinical trial of another investigational pulsed field ablation (PFA) device, opening a new front in its pursuit of a potentially significant cardiovascular opportunity.

The treatment of the first patients with the Omnypulse catheter comes months after J&J posted data on Varipulse, another PFA device to treat atrial fibrillation. J&J also has a PFA and radiofrequency dual energy device in late-phase development.

Omnypulse expands J&J’s portfolio of investigational devices with a catheter that gathers contact force data to support mapping. Analysts have identified the combination of PFA and mapping, which J&J sees as a key feature of its systems, as a threat to Abbott’s electrophysiology unit.

Dive Insight
It has been only three weeks since Boston Scientific notched a milestone in the race for the first-generation PFA market with positive clinical trial results. Boston Scientific and Medtronic are leading the way. Stifel analysts expect the two companies to capture 60% of an atrial fibrillation market, but J&J is aiming to claim a piece of the emerging opportunity.

Until now, J&J’s pursuit of the PFA opportunity has focused on its Varipulse catheter and Thermocool Smarttouch SF dual-energy device. Now, the company, working through its Biosense Webster subsidiary, has started clinical development of another investigational device.

Like Varipulse, the Omnypulse catheter receives a pulse from J&J’s Trupulse generator and integrates with its Carto system to support mapping. Omnypulse adds contact force feedback. J&J previously found benefits to collecting contact force data when performing radiofrequency ablation, although a nonclinical study funded by Medtronic showed it had minimal effects in PFA procedures.

J&J is running a non-randomized study of 135 patients in Europe and Canada to show the results of using contact force feedback with PFA in humans. A hospital in Belgium recently treated the first participants in the clinical trial.

“In the cases I performed as part of the Omny-IRE trial, the contact force data from the Omnypulse Catheter aided the initial map creation in the Carto 3 System, and the integrated PF Index module allowed me to correlate my ablation parameters with the lesion creation,” AZ Sint-Jan Hospital’s Mattias Duytschaever said in a statement from J&J.

The clinical trial has an estimated primary completion date of April 2025. By then, first-generation PFA devices from Boston Scientific, J&J and Medtronic may already be on the U.S. market, suggesting new products will need differentiating features to generate significant sales.

https://www.medtechdive.com/news/johnson-jj-study-pulsed-field-ablation-catheter-mapping-feedb/694047/